Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function

Type 1 Diabetes Clinical Trial

Official title:

Clinical Efectivity of Two Different Sensor-augmented Pumps With Low Predictive Suspension Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04741685
• Other study ID #: C-380
• Status: Completed
• Start date: February 15, 2021
• Est. completion date: June 10, 2021

Study information

• Verified date: June 2021
• Source: Castilla-La Mancha Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Observational cross-sectional multicenter study about effectiveness of two different sensor augmented-pumps with low glucose predictive function in Type 1 Diabetes Mellitus (T1DM) adult patients in routine clinical practice.

Description:

Cross-sectional multicenter analysis about clinical effectiveness of two different sensor-augmented pumps, Tandem T Slim X2 with Basal IQ (TTSX2) and Medtronic Minimed 640G with Smartguard (MM640G) in adult patients with type 1 Diabetes mellitus.

All clinical variables are gathered from three EMR softwares and two sensor-augmented pumps sotwares.

Data analysis is conducted using SPSS (Chicago, IL) statistics software. Results are presented as mean ± SD values or percentages. A Kruskal-Wallis or a Friedman test were used for the analysis of differences. Comparisons between proportions were analyzed using a chi-squared test. A "P" value < 0.05 was considered statistically significant.

The protocol was approved by the reference Castilla-La Mancha Public Health Institute Ethic Committee. All participants provided written informed consent.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 10, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Treated with TTSX2 or MM640.

Exclusion Criteria:

• Other kind of diabetes.

• Serious mental disease.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• TTSX2
Treatment with Tandem T Slim X2 with Basal IQ
• MM640G
Treatment with Medtronic Minimed 640G with Smartguard

Locations

Country	Name	City	State
Spain	Badajoz University Hospital	Badajoz
Spain	Obispo Rafael Torija, St.	Ciudad Real
Spain	Nuestra Señora de la Candelaria University Hospital	Tenerife	Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor	Collaborator
Castilla-La Mancha Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIR	time in range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose	during the procedure
Secondary	TBR	time below range (TBR, <70 mg/dL, <3.9 mmol/L) of the interstitial glucose	during the procedure
Secondary	TAR	time above range (TIR, 70-180 mg/dL, 3.9-10 mmol/L) of the interstitial glucose	during the procedure
Secondary	HbA1C	Glycate haemoglobina A1C	during the procedure
Secondary	GMI	Glucose management index	during the procedure
Secondary	MAGE	Mean amplitude glucose excursions	during the procedure
Secondary	%CV	Coefficient of variation percentage of the intersticial glucose	14 days
Secondary	DQOL	Diabetes quality of life (EsDQOL questionnary score), 43 questions, each question with a score from 1 to 5, worse score is five points.	during the procedure
Secondary	Hypoglycemia perception 1	Hypoglycemia unawareness (Clarke questionnary score), 8 questions, each one score "R" or "not R", more "R" means worse score.	during the procedure
Secondary	Hypoglycemia perception 2	Hypoglycemia unawareness (Gold questionnary scores), single question, score from 0 to 5, worse score is five points.	during the procedure